Unité de Chirurgie de la Colonne Vertébrale
Bruges, 33520, France
NCT Number: NCT04914728
Degenerative lumbar pathologies are characterised by functional impairment and the occurrence of severe chronic pain and disability Arthrodesis of the lumbar spine is a common surgery for the treatment of degenerative lumbar pathologies. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The development of mini-invasive techniques and the development of the Improved Rehabilitation after Surgery programmes, has considerably reduced the hospital stay of the patients. It is possible that in the future mini-invasive lumbar arthrodesis will be performed on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Bruges, 33520, France
Degenerative lumbar disease (DLD) is a condition of increasing frequency, affecting millions of patients worldwide. They are characterised by functional impairment and the occurrence of severe chronic pain and disability.
Arthrodesis of the lumbar spine is a common surgery for the treatment of DLD. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The advent of mini-invasive techniques and the development of Improved Rehabilitation after Surgery program has made it possible to considerably reduce the duration of hospitalization of patients with a high rate of satisfaction, a reduction in costs and without increasing morbidity. In spinal surgery, decompression procedures such as discectomy and lumbar recalibration are frequently performed on an ambulatory. The first American studies with a low level of evidence on the management of mini-invasive lumbar arthrodesis are beginning to appear. It is quite possible that in the future this type of procedure will be carried out on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated. In the United States, 23-hour hospitalizations are considered as ambulatory procedures, whereas in France, ambulatory is qualified as such when the patient is admitted and discharged in the same day.
The study population was patients who had failed medical treatment (analgesics and rehabilitation) for more than three months and who required a mono-segmental arthrodesis procedure for the management of their lumbar-radiculalgia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 24 hours after surgery
Percentage of patients with same-day discharge
Time frame: through study completion, an average of 1 year
Record of adverse event
Time frame: within 1st week
Occurrence of re-hospitalization and/or emergency readmission and/or need for re-operation of the patient
Time frame: within 1st month
Presence of a cicatrization disorder, the occurrence of an infection, neurological damage, adverse event related to the implants, vascular and/or medical problem.
Time frame: within 1st year
occurrence of pseudoarthrosis
Time frame: at 1-month visit
Short Form-36 Health Survey questionnaire
Time frame: at 1-month visit
Evaluated by Oswestry
Time frame: at 6-month visit
Evaluated by Short Form-36 Health Survey questionnaire
Time frame: at 6-month visit
Evaluated by Oswestry
Time frame: at 1-year visit
Evaluated by Short Form-36 Health Survey questionnaire
Time frame: at 1-year visit
Evaluated by Oswestry
Time frame: at 1-month visit
Return to professional activity
Time frame: at 6-month visit
Return to professional activity
Time frame: at 1-year visit
Return to professional activity
Time frame: at 1-month visit
The radiological parameter: L1S1 lumbar lordosis
Time frame: at 1-month visit
The radiological parameter: Segmental lordosis of the arthrodesis level
Time frame: at 1-month visit
The radiological parameter: Pelvic Incidence
Time frame: at 1-month visit
The radiological parameter: Pelvic version
Time frame: at 1-month visit
The radiological parameter: Sacral slope
Time frame: at 1-month visit
The radiological parameter: Disc height
Time frame: at 6-month visit
The radiological parameter: L1S1 lumbar lordosis
Time frame: at 6-month visit
The radiological parameter: Segmental lordosis of the arthrodesis level
Time frame: at 6-month visit
The radiological parameter: Pelvic Incidence
Time frame: at 6-month visit
The radiological parameter: Pelvic version
Time frame: at 6-month visit
The radiological parameter: Sacral slope
Time frame: at 6-month visit
The radiological parameter: Disc height
Time frame: at 1-year visit
The radiological parameter: L1S1 lumbar lordosis
Time frame: at 1-year visit
The radiological parameter: Segmental lordosis of the arthrodesis level
Time frame: at 1-year visit
The radiological parameter: Pelvic Incidence
Time frame: at 1-year visit
The radiological parameter: Pelvic version
Time frame: at 1-year visit
The radiological parameter: Sacral slope
Time frame: at 1-year visit
The radiological parameter: Disc height
Time frame: at 1-month visit
Satisfaction score
Time frame: at 6-month visit
Satisfaction score
Time frame: at 1-year visit
Satisfaction score
Time frame: at 1-month visit
Lumbar Visual Analogue Scales pain
Time frame: at 6-month visit
Lumbar Visual Analogue Scales pain
Time frame: at 1-year visit
Lumbar Visual Analogue Scales pain
Time frame: at 1-month visit
Radicular Visual Analogue Scales pain
Time frame: at 6-month visit
Radicular Visual Analogue Scales pain
Time frame: at 1-year visit
Radicular Visual Analogue Scales pain
Time frame: before the 1-month visit
record of analgesic treatments taken before and after surgery
Elsan
Other
Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study "ALAMBU"
Acronym: ALAMBU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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